Archive for December, 2008

Adverse Event Reporting News - Tegretol USP, chewable tablets, and oral suspension

Monday, December 29th, 2008

Tegretol-XR (carbamazepine extendedrelease tablets)
BOXED WARNING
Serious Dermatologic Reactions and HLA-B*1502 Allele
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported during treatment with Tegretol. These reactions are estimated to occur in 1 to 6 per 10,000 new users in c…

Business Wire - Tegretol®-XR receives clearance for marketing

Wednesday, December 24th, 2008

SUMMIT, N.J.–(HealthWire)–May 2, 1996–Ciba-Geigy Corp. announced today that Tegretol(R)-XR (carbamazepine extended-release tablets), the first extended release anti-epileptic drug, recently received U.S. Food and Drug Administration clearance for marketing.
“Tegretol is a me…

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications

Friday, December 19th, 2008

ROCKVILLE, Md., Dec. 16, 2008-The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products’ prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including thos…

Fda Generic Medication Approval Method Adequacy

Tuesday, December 16th, 2008

The FDA applies a rigid rule of what they call bioequivalence trying to make sure that generic medications are identical medicine with equal effects as the original one. When measured in the laboratory and in the simple, small trials with humans, a generic drug must deliver similar active component in the blood of patient virtually similar amount to almost the same proportion as the original medication.

The Food and Drug Administration…

Epilepsy – Symptoms , Causes and Treatment

Friday, December 12th, 2008

Epilepsy is a common chronic neurological disorder that is characterized by recurrent unprovoked seizures.[1][2] These seizures are transient signs and/or symptoms due to abnormal, excessive or synchronous neuronal activity in the brain.[3] About 50 …

Treating Multiple Sclerosis Pain - Anticonvulsants & New Frontiers in Treatment

Saturday, December 6th, 2008

For the most part, however, acute MS pain can’t be effectively treated with
aspirin, ibuprofen, or other common OTC pain reliever medications or
treatments. “Since most MS pain originates in the central nervous system,
it makes it a lot more difficult to control than joint or muscle pain,”
says Kathleen Hawker, MD, an assistant professor of neurology in the multiple
sclerosis program at the University of Texas Southwestern Medical Center in
Dallas (UTSW).
So what’s the …

Fabry Disease – Causes and Symptoms of Fabry Disease

Thursday, December 4th, 2008

Fabry disease is one of several genetically inherited diseases called lysosomal storage disorders. It causes a wide range of signs and symptoms that can range from mild to severe and life threatening. This site connects the Fabry community to information about the causes, diagnosis and management of Fabry disease. The site also provides support to patients, families, and healthcare providers….

Classification of Lupus Types

Wednesday, December 3rd, 2008

Due to the fact that it involves impairments of the immune system and determines the body to destroy its own healthy cells and tissues, lupus is defined as an autoimmune disease. A major characteristi…